FDA WARNING_LETTER - Supply Center USA - September 02, 2025

The FDA issued a warning letter to Supply Center USA, located at 30 N Gould St Ste R, Sheridan, WY, on August 25, 2025, following a review of their website in May 2025. The inspection revealed that the company offers several unapproved ophthalmic drug products for sale, including various Similasan eye relief products and Boiron Optique 1 Eye Irritation Relief. These products are classified as unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as they are intended for use in diagnosing, curing, mitigating, treating, or preventing diseases without FDA approval.

The FDA highlighted the public health risks associated with these products, as ophthalmic drugs bypass some of the body"s natural defenses. The letter emphasizes that these products are not generally recognized as safe and effective (GRASE) and lack the necessary FDA-approved applications to be legally marketed.

Supply Center USA is required to investigate and address these violations, ensuring compliance with all federal laws and FDA regulations. The company must respond in writing within fifteen working days, detailing corrective actions taken and providing supporting documentation. Failure to comply may result in legal actions, including product seizure and injunctions. The FDA also references previous warning letters issued to Similasan AG and Boiron, Inc. regarding similar issues. Responses should be directed to the FDA"s Office of Unapproved Drugs and Labeling Compliance.